The FDA has approved Novo Nordisk’s Rebinyn coagulation treatment for the treatment of adults and children with hemophilia B.
Rebinyn is indicated for treatment and control of bleeding episodes and the perioperative management of bleeding in adults and children with hemophilia B. It is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B.
Hemophilia B affects an estimated 5000 people in the United States. Factor IX is a naturally occurring clotting factor that is deficient in people with hemophilia B.
The active substance in Rebinyn, nonacog beta pegol, is a recombinant coagulation factor IX. It replaces the missing factor IX, thereby helping the blood to clot and giving temporary control of bleeding.
Rebinyn, given by infusion, is indicated for “on-demand treatment and control of bleeding episodes, and the perioperative management of bleeding in adults and children with hemophilia B,” the company said in a news release. It is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B.
Novo Nordisk expects to launch Rebinyn in the first half of 2018.